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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR180.25]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 180 -- FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

Subpart B--Specific Requirements for Certain Food Additives

Sec. 180.25 Mannitol.

(a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol (C6H14O6) a hexahydric alcohol, differing from sorbitol principally by having a different optical rotation. Mannitol is produced by one of the following processes:

(1) The electrolytic reduction or transition metal catalytic hydrogenation of sugar solutions containing glucose or fructose.

(2) The fermentation of sugars or sugar alcohols such as glucose, sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces rouxii.

(3) A pure culture fermentation of sugars such as fructose, glucose, or maltose using the nonpathogenic, nontoxicogenic bacterium Lactobacillus intermedius (fermentum ).

(b) The ingredient meets the specifications of the "Food Chemicals Codex," 3d Ed. (1981), pp. 188-190, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as an anticaking agent and free-flow agent as defined in 170.3(o)(1) of this chapter, formulation aid as defined in 170.3(o) (14) of this chapter, firming agent as defined in 170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in 170.3(o)(12) of this chapter, lubricant and release agent as defined in 170.3(o)(18) of this chapter, nutritive sweetener as defined in 170.3(o)(21) of this chapter, processing aid as defined in 170.3(o)(24) of this chapter, stabilizer and thickener as defined in 170.3(o)(28) of this chapter, surface-finishing agent as defined in 170.3(o)(30) of this chapter, and texturizer as defined in 170.3(o)(32) of this chapter.

(d) The ingredient is used in food at levels not to exceed 98 percent in pressed mints and 5 percent in all other hard candy and cough drops as defined in 170.3(n)(25) of this chapter, 31 percent in chewing gum as defined in 170.3(n)(6) of this chapter, 40 percent in soft candy as defined in 170.3(n)(38) of this chapter, 8 percent in confections and frostings as defined in 170.3(n)(9) of this chapter, 15 percent in nonstandardized jams and jellies, commercial, as defined in 170.3(n)(28) of this chapter, and at levels less than 2.5 percent in all other foods.

(e) The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 20 grams of mannitol shall bear the statement "Excess consumption may have a laxative effect".

(f) In accordance with 180.1, adequate and appropriate feeding studies have been undertaken for this substance. Continued uses of this ingredient are contingent upon timely and adequate progress reports of such tests, and no indication of increased risk to public health during the test period.

(g) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996; 69 FR 65542, Nov. 15, 2004]

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